[Federal Register Volume 68, Number 151 (Wednesday, August 6, 2003)]
[Notices]
[Pages 46616-46619]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-20014]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2003-0240; FRL-7319-3]


Cyromazine; Notice of Filing of Pesticide Petitions to Establish 
a Tolerance for a Certain Pesticide Chemical in or on Food

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of pesticide 
petitions proposing the establishment of regulations for residues of a 
certain pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket ID number OPP-2003-0240, must be 
received on or before September 5, 2003.

ADDRESSES:  Comments may be submitted electronically, by mail, or 
through hand delivery/courier. Follow the detailed instructions as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-3194; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does This Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
    [sbull] Industry (NAICS 111, 112, 311, 32532), e.g., Crop 
production, Animal production, Food manufacturing, and Pesticide 
manufacturing.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2003-0240. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The docket telephone number is (703) 305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.
    Certain types of information will not be placed in the EPA Dockets. 
Information claimed as CBI and other information whose disclosure is 
restricted by statute, which is not included in the official public 
docket, will not be available for public viewing in EPA's electronic 
public docket. EPA's policy is that copyrighted material will not be 
placed in EPA's electronic public docket but will be available only in 
printed, paper form in the official public docket. To the extent 
feasible, publicly available docket materials will be made available in 
EPA's electronic public docket. When a document is selected from the 
index list in EPA Dockets, the system will identify whether the 
document is available for viewing in EPA's electronic public docket. 
Although not all docket materials may be available electronically, you 
may still access any of the publicly available docket materials through 
the docket facility identified in Unit I.B. EPA intends to work towards 
providing electronic access to all of the publicly available docket 
materials through EPA's electronic public docket.
    For public commenters, it is important to note that EPA's policy is 
that public comments, whether submitted electronically or in paper, 
will be made available for public viewing in EPA's electronic public 
docket as EPA receives them and

[[Page 46617]]

without change, unless the comment contains copyrighted material, CBI, 
or other information whose disclosure is restricted by statute. When 
EPA identifies a comment containing copyrighted material, EPA will 
provide a reference to that material in the version of the comment that 
is placed in EPA's electronic public docket. The entire printed 
comment, including the copyrighted material, will be available in the 
public docket.
    Public comments submitted on computer disks that are mailed or 
delivered to the docket will be transferred to EPA's electronic public 
docket. Public comments that are mailed or delivered to the docket will 
be scanned and placed in EPA's electronic public docket. Where 
practical, physical objects will be photographed, and the photograph 
will be placed in EPA's electronic public docket along with a brief 
description written by the docket staff.

C. How and to Whom Do I Submit Comments?

    You may submit comments electronically, by mail, or through hand 
delivery/courier. To ensure proper receipt by EPA, identify the 
appropriate docket ID number in the subject line on the first page of 
your comment. Please ensure that your comments are submitted within the 
specified comment period. Comments received after the close of the 
comment period will be marked ``late.'' EPA is not required to consider 
these late comments. If you wish to submit CBI or information that is 
otherwise protected by statute, please follow the instructions in Unit 
I.D. Do not use EPA Dockets or e-mail to submit CBI or information 
protected by statute.
    1. Electronically. If you submit an electronic comment as 
prescribed in this unit, EPA recommends that you include your name, 
mailing address, and an e-mail address or other contact information in 
the body of your comment. Also include this contact information on the 
outside of any disk or CD ROM you submit, and in any cover letter 
accompanying the disk or CD ROM. This ensures that you can be 
identified as the submitter of the comment and allows EPA to contact 
you in case EPA cannot read your comment due to technical difficulties 
or needs further information on the substance of your comment. EPA's 
policy is that EPA will not edit your comment, and any identifying or 
contact information provided in the body of a comment will be included 
as part of the comment that is placed in the official public docket, 
and made available in EPA's electronic public docket. If EPA cannot 
read your comment due to technical difficulties and cannot contact you 
for clarification, EPA may not be able to consider your comment.
    i. EPA Dockets. Your use of EPA's electronic public docket to 
submit comments to EPA electronically is EPA's preferred method for 
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket, and follow the online instructions for submitting comments. 
Once in the system, select ``search,'' and then key in docket ID number 
OPP-2003-0240. The system is an ``anonymous access'' system, which 
means EPA will not know your identity, e-mail address, or other contact 
information unless you provide it in the body of your comment.
    ii. E-mail. Comments may be sent by e-mail to [email protected], 
Attention: Docket ID Number OPP-2003-0240. In contrast to EPA's 
electronic public docket, EPA's e-mail system is not an ``anonymous 
access'' system. If you send an e-mail comment directly to the docket 
without going through EPA's electronic public docket, EPA's e-mail 
system automatically captures your e-mail address. E-mail addresses 
that are automatically captured by EPA's e-mail system are included as 
part of the comment that is placed in the official public docket, and 
made available in EPA's electronic public docket.
    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM 
that you mail to the mailing address identified in Unit I.C.2. These 
electronic submissions will be accepted in WordPerfect or ASCII file 
format. Avoid the use of special characters and any form of encryption.
    2. By mail. Send your comments to: Public Information and Records 
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001, Attention: Docket ID Number OPP-2003-0240.
    3. By hand delivery or courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Office of Pesticide 
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 
2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket 
ID Number OPP-2003-0240. Such deliveries are only accepted during the 
docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI to the Agency?

    Do not submit information that you consider to be CBI 
electronically through EPA's electronic public docket or by e-mail. You 
may claim information that you submit to EPA as CBI by marking any part 
or all of that information as CBI (if you submit CBI on disk or CD ROM, 
mark the outside of the disk or CD ROM as CBI and then identify 
electronically within the disk or CD ROM the specific information that 
is CBI). Information so marked will not be disclosed except in 
accordance with procedures set forth in 40 CFR part 2.
    In addition to one complete version of the comment that includes 
any information claimed as CBI, a copy of the comment that does not 
contain the information claimed as CBI must be submitted for inclusion 
in the public docket and EPA's electronic public docket. If you submit 
the copy that does not contain CBI on disk or CD ROM, mark the outside 
of the disk or CD ROM clearly that it does not contain CBI. Information 
not marked as CBI will be included in the public docket and EPA's 
electronic public docket without prior notice. If you have any 
questions about CBI or the procedures for claiming CBI, please consult 
the person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Make sure to submit your comments by the deadline in this 
notice.
    7. To ensure proper receipt by EPA, be sure to identify the docket 
ID number assigned to this action in the subject line on the first page 
of your response. You may also provide the name, date, and Federal 
Register citation.

II. What Action is the Agency Taking?

    EPA has received a pesticide petition as follows proposing the 
establishment and/or amendment of regulations for residues of a certain 
pesticide chemical in or on various food commodities under section 408 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that this petition contains data or information 
regarding the elements set forth in FFDCA section 408(d)(2);

[[Page 46618]]

however, EPA has not fully evaluated the sufficiency of the submitted 
data at this time or whether the data support granting of the petition. 
Additional data may be needed before EPA rules on the petition.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives, 
Food additives, Pesticides and pests, Reporting and recordkeeping 
requirements.

    Dated: July 28, 2003.
Debra Edwards,
Director, Registration Division, Office of Pesticide Programs.

Summary of Petitions

    The petitioner summary of the pesticide petitions are printed below 
as required by FFDCA section 408(d)(3). The summary of the petitions 
were prepared by the petitioner and represents the view of the 
petitioner. The petition summary announces the availability of a 
description of the analytical methods available to EPA for the 
detection and measurement of the pesticide chemical residues or an 
explanation of why no such method is needed.

Interregional Research Project Number 4 (IR-4)

PP 2E6507 and PP 2E6510

    EPA has received pesticide petitions (PP 2E6507 and PP 2E6510) from 
IR-4, 681 U.S. Highway 1 South, North Brunswick, NJ 08902-3390 
proposing, pursuant to section 408(d) of FFDCA, 21 U.S.C. 346a(d), to 
amend 40 CFR 180.414 by establishing tolerances for residues of 
cyromazine, (N-cyclopropyl-1,3,5-triazine-2,4,6-triamine) in or on the 
following raw agricultural commodities: Leek; onion, green; onion, 
potato; onion, tree; onion, welsh; and shallot, fresh leaves at 3.0 
parts per million (ppm) (2E6507), garlic, bulb; garlic great-headed, 
bulb; onion, dry bulb; rakkyo, bulb; and shallot, bulb at 0.2 ppm 
(2E6507), vegetable brassica, leafy, group 5, except broccoli at 10 ppm 
(2E6510), broccoli at 1.0 ppm, turnip, greens; cabbage, abyssinian; 
cabbage, seakale; and hanover salad, leaves at 10 ppm, and kidney of 
cattle, goats, hogs, horses, and sheep at 0.2 ppm, and meat byproducts 
of cattle, goats, hogs, horses, and sheep at 0.05 ppm (2E6510). IR-4 
also proposed that tolerances for residues of cyromazine in or on dry 
bulb onion at 2.0 ppm and green onion at 0.1 ppm established under 40 
CFR 180.414(a) and Chinese cabbage and Chinese mustard at 3.0 ppm 
established under 40 CFR 180.414(c) be deleted when the proposed 
tolerances are established. Chinese cabbage and Chinese mustard are 
included in the Brassica leafy vegetable group. EPA has determined that 
the petitions contain data or information regarding the elements set 
forth in section 408(d)(2) of the FFDCA; however, EPA has not fully 
evaluated the sufficiency of the submitted data at this time or whether 
the data support granting of the petitions. Additional data may be 
needed before EPA rules on the petitions. This summary has been 
prepared by the Syngenta Crop Protection Incorporated.

A. Residue Chemistry

    1. Plant metabolism. The metabolism of cyromazine in plants is 
adequately understood for the purposes of these tolerances.
    2. Analytical method. Methods AG-408 and AG-417 as listed in the 
Food and Drug Administration's Pesticide Analytical Manual (PAM), Vol-
II are adequate to enforce the proposed tolerances.
    3. Magnitude of residues. Residue field tests were conducted in 
typical growing regions for Brassica and bulb vegetables and turnip 
tops. The data collected support the proposed tolerances of 10.0 ppm 
for Brassica leafy vegetables, 10.0 ppm for turnip tops and 3.0 ppm for 
bulb vegetables.

B. Toxicological Profile

    1. Acute. A rat acute oral toxicity study with a lethal dose 
(LD)50 of approximately 3,387 milligrams/kilogram (mg/kg) 
(toxicity category III; moderately toxic). A rat acute dermal toxicity 
study with a LD50 greater than 3,100 mg/kg (toxicity 
category III; moderately toxic). A rat acute inhalation study with a 
lethal concentration (LC)50 greater than 2.9 mg/kg (toxicity 
category IV; slightly toxic). A primary eye irritation study in the 
rabbit that showed no eye irritation. A primary dermal irritation study 
in the rabbit that showed mild irritation (toxicity category; IV). A 
dermal sensitization study in the guinea pig that showed no 
sensitization.
    2. Genotoxicity. Studies on gene mutation and other genotoxic 
effects showed no evidence of point mutation in an Ames test; no 
indication of mutagenic effects in a dominant lethal test; and no 
evidence of mutagenic effects in a nucleus anomaly test in Chinese 
hamsters.
    3. Reproductive and developmental toxicity. In a rat developmental 
toxicity study, the maternal no observed adverse effect level (NOAEL) 
was 100 mg/kg/day. The maternal lowest observed adverse effect level 
(LOAEL) was 300 mg/kg based on decreased body weight gain and clinical 
observations. The developmental NOAEL was 300 ppm. The developmental 
LOAEL was 600 mg/kg based upon an increase of minor skeletal variation.
    In a rabbit developmental toxicity study, the maternal NOAEL was 10 
mg/kg. The maternal LOAEL was 30 mg/kg based upon decreased body weight 
gain and food consumption. The developmental NOAEL/LOAEL was greater 
than or equal to 60 mg/kg.
    In a multi-generation study in rats, the systemic NOAEL was 30 ppm 
(1.5 mg/kg). The systemic LOAEL was 1,000 ppm (50 mg/kg) based upon 
decreased body weights associated with decreased food consumption. The 
developmental/offspring systemic NOAEL was 1,000 ppm. The 
developmental/offspring systemic LOAEL was 3,000 ppm (150 mg/kg) based 
upon decreased body weight at birth through weaning. There were no 
effects on reproductive parameters at the highest dose tested (HDT) 
(3,000 ppm).
    4. Subchronic toxicity. In a 6-month feeding study in dogs, the 
NOAEL was 30 ppm (0.75 mg/kg). The LOAEL was 300 ppm (7.5 mg/kg) based 
upon decreased hematocrit and decreased hemoglobin. Groups of male and 
female beagle dogs (4/sex/dose) were fed diets containing cyromazine at 
0, 30, 300, or 3,000 ppm (0, 0.75, 7.5, or 75 mg/kg/day, respectively) 
for 6-months. No treatment-related effects were observed in survival, 
clinical signs or body weight parameters. Pronounced effects on 
hematologic parameters were manifested as decreases in hematocrit and 
hemoglobin levels at 300 and 3,000 ppm.
    5. Chronic toxicity. In a 24-month feeding study in rats the NOAEL 
for the study was 30 ppm (1.5 mg/kg/day). The LOAEL was 300 ppm (15.0 
mg/kg) based on decreased body weight. In a 24-month mouse chronic 
feeding carcinogenicity study the NOAEL was 50 ppm (7.5 mg/kg/day). The 
LOAEL was 1,000 ppm (150.0 mg/kg) based upon decreased body weight. 
There was no evidence of carcinogenicity at 3,000 ppm (450 mg/kg). In a 
24-month rat chronic feeding carcinogenicity study the NOAEL was 
greater than 3,000 ppm (150 mg/kg) (HDT). There was no evidence of 
carcinogenicity at 3,000 ppm.
    Cancer Peer Review Committee determined that there is no evidence 
of carcinogenicity in studies in either the mouse or rat. Based upon 
this determination it can be concluded that cyromazine does not pose a 
cancer risk.

[[Page 46619]]

    6. Animal metabolism. The metabolism of cyromazine has been 
adequately characterized in the rat, goat, and chicken.
    7. Metabolite toxicology. EPA has removed melamine, a metabolite of 
cyromazine, from the tolerance expression as a residue of toxicological 
concern. For more information on melamine, see the Federal Register of 
September 15, 1999 (64 FR 50043) (FRL-6098-7).
    8.  Endocrine disruption. Cyromazine does not belong to a class of 
chemicals proven to have adverse effects on the endocrine system. There 
is no evidence that cyromazine has any effect on endocrine function in 
developmental or reproduction studies.

C. Aggregate Exposure

    1. Dietary exposure--Food. For the purposes of assessing the 
potential dietary exposure under the proposed tolerances, Syngenta Crop 
Protection has estimated aggregate exposure from all crops for which 
tolerances are established.
    i. Acute. There were no toxicological effects attributed to a 
single exposure (dose) observed in oral toxicity studies including the 
developmental toxicity studies in rats and rabbits. Therefore, there is 
a reasonable certainty of no harm from acute dietary exposure.
    ii. Chronic. The cyromazine chronic dietary exposure assessment 
utilized the Dietary Exposure Evaluation Model (DEEM[reg]), version 
7.76 from Exponent. All consumption data from this assessment were 
taken from the USDA's Continuing Survey of Food Intake by Individuals 
(CSFII) with the 1994-96 consumption database and the Supplemental 
CSFII children's survey (1998) consumption database.
    The cyromazine Tier III chronic dietary exposure assessment was 
based upon residue field trial results, and tolerance residues for 
crops when no field trial data were available. Anticipated residue 
estimates were used for milk, meat, fat, and meat by-products of 
cattle, goats, hogs, horses, and sheep; and for all other commodities 
tolerance level residues were assumed. The maximum percent crop treated 
values for cyromazine were obtained from the Doane's Market Survey 
Database (1999-2001) and used for lima beans (0.8%), cantaloupe (3.9%), 
peppers (8.6%), tomatoes (2.9%), celery (68.9%), lettuce (9.7%), 
spinach (19.5%), and onions (0.2%). For all other registered or 
proposed crop uses, it was assumed that 100% of these crops were 
treated.
    2. Drinking water. EPA uses the FQPA Index Reservoir Screening Tool 
(FIRST) to estimate pesticide concentrations in surface water and 
screening concentration in ground water (SCI-GROW) to estimate 
pesticide concentrations in ground water. FIRST incorporates an index 
reservoir environment and includes a percent crop area factor as an 
adjustment to account for the maximum percent crop coverage within a 
watershed or drainage basin.
    None of these models include consideration of the impact that 
processing (mixing, dilution, or treatment) would have on the removal 
of pesticides from the water source. The primary use of these models by 
EPA is to provide a Tier I assessment to estimate the concentration of 
pesticides in drinking water.
    Estimated Environmental Concentrations (EECs) of cyromazine in 
drinking water were determined for the highest use rate of cyromazine. 
Based on the model outputs, the EECs of cyromazine are 1.8 parts per 
billion (ppb) for chronic exposure to ground water and 10 ppb for 
chronic exposure to surface water.
    3. Non-dietary exposure. Cyromazine is currently registered for 
commercial outdoor use on landscape ornamentals and commercial 
interiorscapes. There are no lawn or indoor residential uses and 
significant residential exposure is not expected.

D. Cumulative Effects

    When considering whether to establish, modify, or revoke a 
tolerance, section 408(b)(2)(D)(v) requires that the Agency consider 
``available information'' concerning the cumulative effects of a 
particular pesticide's residue and ``other substances that have a 
common mechanism of toxicity.'' Neither Syngenta nor EPA has at this 
time, data available to determine whether cyromazine has a common 
mechanism of toxicity with other substances or the methodology to 
include this pesticide in a cumulative risk assessment. Unlike other 
pesticides for which EPA has followed a cumulative risk approach based 
on a common mechanism of toxicity, cyromazine does not appear to 
produce a toxic metabolite produced by other substances.

E. Safety Determination.

    1. Acute risk. There were no toxicological effects observed in oral 
toxicity studies, including the developmental toxicity studies in rats 
and rabbits, that could be attributed to a single exposure (dose). 
Since there is a reasonable certainty of no harm from acute dietary 
exposure, an acute aggregate risk assessment was not performed for 
cyromazine.
    2. Chronic risk. The chronic dietary exposure risk analysis (food 
only) showed that exposure from all established and these proposed 
tolerances would be 2.9% of the chronic reference dose (cRfD) for the 
most exposed subpopulation, children 1 to 2 years old. EPA has 
determined that reliable data support using the standard margin of 
exposure and uncertainty factor (100 for combined interspecies and 
intraspecies variability) for cyromazine and an additional safety 
factor of 10X is not necessary to protect infants and children.
    3. Drinking water. The chronic drinking water level of concern 
(DWLOC) for the most exposed subpopulation (children 1-6 years) is 728 
ppb. Based upon the SCI-GROW and FIRST model outputs, the EECs of 
cyromazine in surface water and ground water are below the chronic 
DWLOC; therefore, EPA should not have a concern regarding cyromazine in 
drinking water.
    4. Non-dietary exposure. Due to the nature of the non-dietary use, 
the commercial use of cyromazine on landscape ornamentals will not 
result in any significant residential exposure.
    Syngenta has considered the potential aggregate exposure from food, 
water, and non-occupational exposure routes and concluded that 
aggregate exposure is not expected to exceed 100% of the cRfD. 
Therefore, Syngenta has concluded that there is reasonable certainty 
that no harm will result from aggregate exposure to cyromazine 
residues.

F. International Tolerances.

    The U.S. tolerances and Codex Maximum Residue Levels (MRLs) are 
compatible for ruminant tissue, bell pepper, and tomato. Codex MRLs and 
U.S. tolerances are incompatible for milk, celery, cucumber, lettuce, 
melon, and mushroom.
[FR Doc. 03-20014 Filed 8-5-03; 8:45 am]
BILLING CODE 6560-50-S